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Medical devices - tragedy and triumph

The rapid development in the potency and complexity of medical devices, while offering great advances in medical care also presents growing challenges to safety and quality, the Consumers Health Forum says.

The latest edition of the Consumers Health Forum’s journal, Health Voices, published today (29 November 2017), presents a dozen articles which explore the positives and pitfalls of medical devices.

“Medical devices --- tragedy and triumphis the title of this edition of Health Voices and that conveys the challenge that we face in attempting to ensure we get the best out of modern biotechnology without unleashing undue risks to patients,” the CEO of the Consumers Health Forum, Leanne Wells, said.

“Australia’s experience with the pelvic mesh tragedies has been the latest episode to indicate the shortcomings of our regulatory system. Earlier episodes of regulatory deficiencies including with metal-on-metal hip prostheses and breast implants demonstrate the difficulties in keeping track of the safety and quality of biotechnology developments in Australia and overseas.

“While the Therapeutic Goods Administration is introducing reforms to strengthen regulatory safeguards, more needs to be done to encourage doctors to report adverse outcomes with medical devices. Medical specialists need to take more responsibility for protecting the interests of their patients. It is disturbing that there is no mandatory requirement for health professionals to report adverse events with medical devices.

“Danny Vadasz of the Health Issues Centre questions why 100 variants of poorly tested pelvic mesh products got on to the market without adequate clinical testing for safety and efficacy and how complaint mechanisms failed to detect an alarming pattern of mesh related complaints.

“The widespread use of pelvic mesh occurred because for most patients the product improved their lives. But for thousands of women, pelvic mesh proved a catastrophe. And that experience highlights the dilemma confronting consumers, doctors and regulators.

“It’s a challenge that requires vigorous and timely reporting systems to detect early markers --- both positive and negative --- of lived experience with medical devices.

“But as this edition of Health Voices shows, the unrelenting advance in biotechnology is posing ever more exacting challenges in ensuring the best safety and quality outcomes for patients. Innovations such as 3D printing enabling the production of custom-made body parts, medical apps that collect patient data and remotely controlled devices such as pacemakers require more sophisticated kinds of safety and quality measures.

“As bioethicist Dr Mary Jean Walker writes, customisation poses new kinds of challenge. With 3D printing for instance, the unprecedented accessibility of this kind of manufacture may make it difficult for regulators to capture all uses of 3D printing. Clinicians and researchers may engage in creating “bespoke” devices without being aware of regulatory controls and without experience in quality assurance practices, putting patients at risk, she says.

“Given previous experience with medical devices and the likely blurring in responsibilities for oversight in the future, the role of consumer advocates will become more important than ever,” Ms Wells said.

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Consumers Health Forum of Australia receives funding from the Australian Government as the peak national healthcare consumer organisation under the Health Peak and Advisory Bodies Programme.